FDA Chief Set to Visit India Amidst Heated Drug Patent Debate

U.S. Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg is set to take an eight-day trip to India later this month to meet with policy, government, and medical industry leaders.

The visit is intended to increase the FDA's presence in India, the largest overseas manufacturer of drugs used in the U.S. There are roughly 150 FDA-approved medical product plants in India. India is also responsible for producing nearly 40 percent of the over-the-counter and generic products used in the U.S.

Hamburg said the trip, which includes stops in Delhi, Kochi, and Mumbai, will cover topics ranging from the conduct of clinical trials to jointly addressing product safety issues.

“The FDA’s ongoing engagement with our regulatory counterparts in India is critical to our ability to effectively promote the health and safety of American and Indian consumers,” said Hamburg said in a statement this week. “I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration.”

Requests to FDA officials for more information regarding Hamburg’s visit were not returned Friday.

India’s presence in the U.S. healthcare market is not only large but also complicated, as many companies there have been accused of making cheaper versions of U.S. patent-protected drugs with the permission of Indian courts.

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India’s Role in the U.S. Drug Market

India has played a critical role in manufacturing low-cost pharmaceuticals used all over the world, including in developing countries.

The latest example is from Mylan Inc. One of the world’s largest generic drug makers, Mylan is set to begin producing the world's first trastuzumab biosimilar in India. In the U.S., trastuzumab is sold under the brand name Herceptin, and it is used to treat HER2-positive metastatic breast cancer. Roche, the Swiss company that owns the patent on Herceptin, is suing Mylan, as well as the Drug Controller General of India.

Reuters reported this week that global drug makers are urging U.S. leaders—including the FDA—to enforce patents to prevent Indian companies from producing their drugs at a significantly lower cost. They also reported that Indian government officials are considering using compulsory licenses to get around these patents in order to create more affordable medicines.

Some consider Indian manufacturers to be the Robin Hoods of medicine, taking drug formulas from large companies and producing generics at a fraction of the cost.

But India remains on the U.S.’s Priority Watch List because of the way it handles American patents and copyrights. U.S. Trade Representatives cite India’s policies regarding pharmaceuticals as an area that needs attention.

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Some Indian Drug Companies Fail Inspections

Indian drug manufacturers are known for creating more affordable medications than their U.S. counterparts, but the industry has now come to the attention of safety inspectors several times.

For example, Wockhardt Ltd, a manufacturer of sterile injectable drugs and insulin, came under FDA fire in September for various violations, including sanitary concerns, poor data keeping, and faulty laboratory practices, Reuters reported.

Most recently, the FDA banned all products from entering the U.S. from Ranbaxy Laboratories, Ltd.’s Toansa plant. In January, FDA inspectors found numerous violations, including flies “too numerous to count” in a sample storage room.

The company's three other plants—Mohali, Paonta Sahib, and Dewas—have been blacklisted by the FDA, according to The Indian Express.

Last March, the FDA added seven more inspectors to its team in India, bringing its total staff there to 19. 

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